BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    IN SWN NCK CRL CATH 38.9CM 2CF

    MDR report key: 5644131 · Received May 10, 2016

    Report

    Report Number
    3009211636-2016-00208
    Event Type
    Malfunction
    Date Received
    May 10, 2016
    Date of Event
    December 2, 2015
    Report Date
    May 4, 2016
    Manufacturer
    COVIDIEN
    Product Code
    MSD
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    SUBMIT DATE: 5/10/2016. AN INVESTIGATION IS CURRENTLY UNDER WAY; UPON COMPLETION THE RESULTS WILL BE FORWARDED. (B)(4).

    Additional Manufacturer Narrative · 1

    SUBMIT DATE: 07/19/2016. A DEVICE HISTORY RECORD REVIEW COULD NOT BE PERFORMED BECAUSE A LOT NUMBER WAS NOT RECEIVED WITH THE COMPLAINT. AS PART OF OUR MANUFACTURING PROCESS, ALL DEVICE HISTORY RECORDS ARE REVIEWED AND APPROVED BY QUALITY, PRIOR TO RELEASE OF PRODUCT. A SAMPLE WAS RECEIVED FOR EVALUATION. A VISUAL AND FUNCTIONAL TEST WAS PERFORMED ON THE SAMPLE. THE CATHETER DID NOT PRESENT ANY LEAKS. THE TRANSFER SET WAS ALSO RECEIVED AND TESTED. LEAKAGE WAS FOUND ON THE TRANSFER SET; HOWEVER, THE TRANSFER SET WAS NOT MANUFACTURED BY COVIDIEN. IT IS POSSIBLE THAT THE TRANSFER SET WAS LEAKING AND THE PHYSICIAN ASSOCIATED THE LEAK WITH THE CATHETER. THE REPORTED ISSUE COULD NOT BE CONFIRMED AND A ROOT CAUSE COULD NOT BE DETERMINED SINCE THE ISSUE WAS DISCOVERED WITH A PRODUCT THAT WAS NOT MANUFACTURED BY COVIDIEN. A CORRECTIVE ACTION IS NOT REQUIRED AT THIS TIME. IT MUST BE NOTED THAT IN-PROCESS CONTROLS (SUCH AS PERSONNEL TRAINING, INCOMING QUALITY ACCEPTANCE TESTING FOR RAW MATERIAL, 100% IN PROCESS VISUAL INSPECTION AND VISUAL ACCEPTANCE SAMPLING) ARE IN PLACE TO PREVENT NON-CONFORMING PRODUCT FROM LEAVING THE MANUFACTURING OPERATIONS. THIS COMPLAINT WILL BE USED FOR TRACKING AND TRENDING PURPOSES.

    Description of Event or Problem · 1

    IT WAS REPORTED TO COVIDIEN ON (B)(6) 2016 THAT A CUSTOMER HAD AN ISSUE WITH A DIALYSIS CATHETER. THE CUSTOMER REPORTS THAT THE CAP HAS LEAKED SINCE THE CATHETER WAS IMPLANTED. THE CATHETER WAS REMOVED DURING AN OPERATIVE PROCEDURE IN CONJUNCTION WITH A KIDNEY TRANSPLANT. THE CATHETER WAS ORIGINALLY PLACED ON (B)(6) 2014 AND PULLED (B)(6) 2015. THERE WAS NO PATIENT INJURY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    300639 IN SWN NCK CRL CATH 38.9CM 2CF DIALYSIS CATHETER MSD COVIDIEN 8888413100

    Patients

    Seq Age Sex Outcome Treatment
    1